NCT03613454: ELSA

Embolization in Splenic Trauma

Completed NA Results posted Last updated 11 August 2021

What this trial tests

NA trial testing Splenic artery embolization with vascular embolic coils in Trauma to the Spleen in 48 participants. Completed in 30 June 2021.

Timeline

16 February 2019

Primary endpoint
3 March 2020

30 June 2021

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	16 February 2019
Primary completion	3 March 2020
Estimated completion	30 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Splenic artery embolization with vascular embolic coils
• Splenic artery embolization with vascular embolic plugs

Conditions studied

• Trauma to the Spleen — all drugs for Trauma to the Spleen →

Sponsor

University of Alabama at Birmingham

Who can join

18 and older, any sex, with Trauma to the Spleen. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Were Enrolled Within 18 Months of Study Initiation Primary · Through study completion, an average of 1 year

The primary outcome of the study will be enrolling 50 participants in the study within 18 months of study initiation with adequate 30 day follow-up on all participants.

Group	Value	95% CI
Splenic Artery Embolization With Vascular Embolic Coils	23
Splenic Artery Embolization With Vascular Embolic Plugs	23

Number of Participants With Embolization Success Secondary · Through study completion, an average of 1 year

This outcome will be measured by the ability of the operator to deploy the required embolic with resultant stasis in the splenic artery. This will be compared between the two groups.

Group	Value	95% CI
Splenic Artery Embolization With Vascular Embolic Coils	22
Splenic Artery Embolization With Vascular Embolic Plugs	20

Number of Participants With Immediate Complications Secondary · During the embolization procedure, an average of 1 hour

This outcome will be measured by the number of intra-procedural complications and compared between the two groups

Group	Value	95% CI
Splenic Artery Embolization With Vascular Embolic Coils	2
Splenic Artery Embolization With Vascular Embolic Plugs	1

Number of Participants With Splenic Salvage Secondary · 30 days after procedure

This outcome will be measured by splenic salvage rate at 30 days and compared between groups. Splenic salvage was defined as the absence of splenectomy in the medical record or per patient report.

Group	Value	95% CI
Splenic Artery Embolization With Vascular Embolic Coils	22
Splenic Artery Embolization With Vascular Embolic Plugs	23

Radiation Exposure Secondary · During the embolization procedure, an average of 1 hour

The radiation exposure during the embolization procedure for each embolic will be measured and compared.

Group	Value	95% CI
Splenic Artery Embolization With Vascular Embolic Coils	250	172 – 671
Splenic Artery Embolization With Vascular Embolic Plugs	380	221 – 675

Contrast Volume Secondary · During the embolization procedure, an average of 1 hour

The amount of contrast used during the procedure will be measured for each group and compared.

Group	Value	95% CI
Splenic Artery Embolization With Vascular Embolic Coils	54	41 – 60
Splenic Artery Embolization With Vascular Embolic Plugs	60	50 – 75

Adverse events — posted to ClinicalTrials.gov

Time frame: Complications were recorded within 30 days from the procedure.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Splenic Artery Embolization With Vascular Embolic Coils

Serious: 1/23 (4%)

Deaths: 1/23

Splenic Artery Embolization With Vascular Embolic Plugs

Serious: 1/23 (4%)

Deaths: 1/23

Serious adverse events (2 terms)

Reaction	System	Splenic Artery Embolizatio…	Splenic Artery Embolizatio…
Coil migration	Surgical and medical procedures	—	—
Vascular injury	Surgical and medical procedures	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Splenic Artery Embolizatio…	Splenic Artery Embolizatio…
Coil migration	Surgical and medical procedures	—	—

Most-reported serious reactions: Coil migration, Vascular injury.

Data from ClinicalTrials.gov NCT03613454 adverse events section.

Sponsor's own description

Randomized, prospective, feasibility study to begin evaluating the efficacy, safety, and cost of using either coils or vascular plugs (VPs) for proximal splenic artery embolization in the setting of traumatic splenic injury.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.